NDC 54838-136

Brotapp DM Cold and Cough

Brompheniramine Maleate And Pseudoephedrine Hydrochloride And Dextromethorphan Hydrobromide

Brotapp DM Cold and Cough is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Lannett Company, Inc.. The primary component is Brompheniramine Maleate; Pseudoephedrine Hydrochloride; Dextromethorphan Hydrobromide.

Product ID54838-136_d31e3f51-016c-47a9-90ab-040bd0c10374
NDC54838-136
Product TypeHuman Otc Drug
Proprietary NameBrotapp DM Cold and Cough
Generic NameBrompheniramine Maleate And Pseudoephedrine Hydrochloride And Dextromethorphan Hydrobromide
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2001-04-05
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameLannett Company, Inc.
Substance NameBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength1 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 54838-136-40

118 mL in 1 BOTTLE, PLASTIC (54838-136-40)
Marketing Start Date2001-04-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54838-136-40 [54838013640]

Brotapp DM Cold and Cough LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2001-04-05

NDC 54838-136-70 [54838013670]

Brotapp DM Cold and Cough LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2001-04-05

Drug Details

Active Ingredients

IngredientStrength
BROMPHENIRAMINE MALEATE1 mg/5mL

OpenFDA Data

SPL SET ID:bc89bbe9-3e31-4dca-a442-b60b696532b7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1098497
  • Medicade Reported Pricing

    54838013670 BROTAPP DM LIQUID

    Pricing Unit: ML | Drug Type:

    54838013640 BROTAPP DM LIQUID

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "Brotapp DM Cold and Cough" or generic name "Brompheniramine Maleate And Pseudoephedrine Hydrochloride And Dextromethorphan Hydrobromide"

    NDCBrand NameGeneric Name
    54838-136Brotapp DM Cold and CoughBrompheniramine maleate and Pseudoephedrine hydrochloride and Dextromethorphan hydrobromide
    68788-0852Q-Tapp DM ElixirBrompheniramine maleate and Pseudoephedrine hydrochloride and Dextromethorphan hydrobromide

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.